Coaxial catheter systems for transference of medium

ABSTRACT

A method, technique and system is disclosed for the delivery of therapeutic agents and/or into the bulk brain tissues and other parts, tissues and organs of the body, including vasculature. A novel form of coaxial catheter provides a means for implanting an outer tube into the brain, then inserting an inner tube into the outer tube and aligning them such that port holes on both of the tubes will overlap and permit a flux of the therapeutic agent to flow into the brain in such a way as to minimize the effects of trapped air, virtually eliminate backflow of the agent, and avoid the potential for additional damage to the brain since only one surgical placement of the outer tube is needed. Similarly, the method, technique system may be utilized to remove fluids or other medium from the brain, tissues, and organs to minimize the effects of escaped air or negative pressure.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims priority from U.S. Provisional PatentApplication Ser. No. 60/591,614, filed Jul. 28, 2004, entitled “CoaxialCatheter Systems for Intraparenchymal Delivery Of Therapeutic Agents,”the disclosure of which is hereby incorporated by reference herein inits entirety.

The present Application is also related to: U.S. patent application Ser.No. 10/444,884, filed May 23, 2003 (U.S. 2003/0204171, published Oct.30, 2003); U.S. Pat. No. 6,599,274; and U.S. patent application Ser. No.11/105,166, filed Apr. 13, 2005, of which all of the disclosures arehereby incorporated by reference herein in their entirety.

BACKGROUND OF THE INVENTION

There are many instances in which a neurosurgeon or other clinicianwould wish to deliver a therapeutic or diagnostic agent into the brainof a patient, for example, for the treatment of primary malignant braintumors. One type of such tumor, glioblastoma multiforme, is a lethalmalignancy of the central nervous system that has proven stubbornlyresistant to the development of any form of satisfactory therapy thatcan either halt the advance of the disease, reverse it, or cure it.Anticancer therapies that are often efficacious in other regions of thebody, such as chemotherapies, are largely ineffective against diffuseneoplasms in the brain in part because of the presence of theblood-brain barrier. Even in the case where the blood-brain barrier is“leaky” within the tumor bed of a glioblastoma multiforme, regionaldelivery into the peritumoral region (which often harbors invadingcells) in which the chemotherapies, gene therapies, and other agents aretargeted is hampered by the intact blood-brain barrier in that region,thus making such approaches unworkable. A means of circumventing suchdelivery problems is offered by the positive pressure infusion of agentsdirectly into the bulk brain tissues, as taught by several workers,examples of which are: U.S. Pat. No. 5,720,720 to Laske, et al., U.S.Pat. No. 6,026,316 to Kucharczyk, et al., and U.S. Pat. No. 6,272,370 toGillies, et al., of which all of the disclosures are hereby incorporatedby reference herein in their entirety. The resulting convection-enhancedflow of infusates through the interstitial space of the brain canprovide for regional volumes of distribution of therapeutic agentswithout the need to have large-molecular weight species traverse theblood-brain barrier. Often, special neurocatheters optimized for thisapproach to drug delivery are needed to maximize the utility of suchtherapies. This general approach to intraparenchymal therapies alsoapplies to the delivery of autologous stem cells into the brain for thetreatment of neurodegenerative disorders, and for the infusion protocolsfor the assessment and treatment of traumatic brain injury. Moreover,positive pressure infusion of therapeutic agents and diagnostic intoother parts or ducts of the body, including the vasculature, is alsopracticed routinely within the field of medicine.

Specialized multi-lumen neurocatheter systems have been disclosed byKucharczyk et al. in U.S. Pat. Nos. 6,599,274 and 6,626,902, of whichboth of the disclosures are hereby incorporated by reference herein intheir entirety. Coaxial catheters for the delivery of cells into thebrain have been disclosed by Kucharczyk et al. in U.S. Pat. No.6,599,274. Several clinical and pre-clinical applications of varioustypes of neurocatheters are discussed in the following publications:Chen, Z.-J., et al., “Intraparenchymal Drug Delivery via PositivePressure Infusion: Experimental and Modeling Studies of Poroelasticityin Brain Phantom Gels,” IEEE Transactions on Biomedical Engineering, 49(2), 85-96, (February 2002), and Broaddus, W. C., et al., “Advances inImage-Guided Delivery of Drug and Cell Therapies into the CentralNervous System,” Neuroimaging Clinics of North America, 11 (4), 727-735,(November 2001), of which all of the disclosures are hereby incorporatedby reference herein in their entirety.

One limitation of the art is that none of the catheters that have beendeveloped to date, nor those foreseen in the literature but not yetimplemented, have been optimized in design for the complete eliminationof reflux of the infused agent along the catheter insertion track orwithin the device structure (particularly if a multi-lumen system isused). The elimination of such reflux would be a desirable feature,especially in instances where the infusate might consist of highlyspecialized and difficult to obtain agents such as certain kinds ofantisense constructs (see Broaddus, W. C., et al., “Strategies for theDesign and Delivery of Antisense Oligonucleotide in Central NervousSystem,” Methods in Enzymology: Antisense Technology, Part. B:Applications, 314, 121-135 (2000), which disclosures is herebyincorporated by reference herein in its entirety), but is generallydesirable for the optimal delivery of any type of diagnostic ortherapeutic agent.

A second limitation of the existing art is that the various types ofmulti-lumen implantable devices fail to include a suitable flush line tovoid the internal components of the catheter of any residual amounts ofa therapeutic (or other) agent that might remain in them after aninitial use, but which should best be removed prior to an additionaluse, as may be performed with a multi-functional catheter, such as thosedisclosed in U.S. Pat. No. 6,026,316 to Kucharczyk; and U.S. Pat. No.6,626,902 to Kucharczyk et al., which are incorporated herein byreference in their entirety.

A third limitation of the art is that the existing multi-lumen catheterdesigns do not allow simultaneous escape of trapped air and sealingagainst inter-tube leakage when an inner lumen is inserted into an outerlumen of such a device.

A fourth limitation of the existing art is that the intra-tube flowdividers inside the inner tube of multi-lumen devices seal at the end ofthe catheter in such a way that there cannot be communication betweenwhat could otherwise function as infusion and flushing channels.

A fifth limitation of the existing art is that many types of existingmulti-lumen, multi-port hole catheters require the use of an internallyinflatable balloon to either enable the drug delivery or port holeselection process. Examples of such devices and associated methods arethose taught by Baran et al. in U.S. Pat. No. 4,423,725, Schweich et al.in U.S. Pat. No. 5,716,340 and Lary in U.S. Pat. No. 6,506,180, of whichall of the disclosures are hereby incorporated by reference herein intheir entirety. A general discussion of clinical applications ofmulti-port hole catheters for imaging of intravascular gene therapy hasbeen presented by Xiaoming Yang, “Imaging of Vascular Gene Therapy,”Radiology, 228 (1), 36-49 (July 2003), of which the disclosure is herebyincorporated by reference herein in its entirety. Other publicationsthat are incorporated by reference herein in their entirety includingthe following: Broaddus, W. C., Gillies, G. T., and Kucharczyk, J.,“Image-Guided Intraparenchymal Drug and Cell Therapy,” in Latchaw, R.E., Kucharczyk, J., and Moseley, M. E., eds., Imaging of the NervousSystem: Diagnostic and Therapeutic Applications, Vol. 2 (Elsevier-Mosby,Philadelphia, 2005), Chap. 72, pp. 1467-1476; Chiocca, E. A., Broaddus,W. C., Gillies, G. T., Visted, T., and Lamfers, M. L. M., “NeurosurgicalDelivery of Chemotherapeutics, Targeted Toxins, Genetic and ViralTherapies in Neuro-Oncology,” Journal of Neuro-Oncology, 69, 101-117,(2004); Gillies, G. T., Smith, J. H., and Humphrey, J. A. C., “PositivePressure Infusion of Therapeutic Agents into Brain Tissues: Mathematicaland Experimental Simulations,” in Yamaguchi, T., ed., Frontiers ofMedical Informatics: Proceedings of the 4^(th) International Symposiumon Future Medical Engineering Based on Bio-Nanotechnology (21^(st)Century COE Program), (Tohoku University, Sendai, Japan, 2004), pp.7-12; and Bauman, M. A., Gillies, G. T., Raghavan, R., Brady, M. L., andPedain, C., “Physical Characterization of Neurocatheter Performance in aBrain Phantom Gelatin with Nanoscale Porosity: Stead-State andOscillatory Flows,” Nanotechnology, 15, 92-97, (2004).

None of the multi-lumen intraparenchymal therapy delivery devicesexisting in the art traverse these limitations, nor does the prior artteach or suggest means, techniques and systems for improving the designsof them such that these limitations would not prevent successfuldiagnostic and therapeutic protocols from being carried out.

Significant and potentially useful advances in the treatment ofglioblastoma multiforme, traumatic brain injury, neurodegenerativedisorders and many other neurological and neurosurgical indicationscould be realized if alternatives to the prior art were able todemonstrate safety and efficacy via improvement of the catheter systemsused for therapy delivery. The various embodiments of the presentinvention disclose a means, technique and system for attempting to reachthis goal by implementation of a novel set of catheter structures,functions and means that traverse the limitations of the existing artdiscussed above and elsewhere.

SUMMARY OF THE INVENTION

Various structures, materials and practices described herein, some ofwhich constitute embodiments of a proprietary invention, provide atleast some of: an improved means of delivering therapeutic anddiagnostic agents into the brain for the assessment and treatment ofsequellae of traumatic brain injury; the diagnosis and treatment ofintracranial neoplasms; the investigation and counteraction ofneurodegenerative disorders; and generally for the neurosurgicalevaluation and treatment of neurological insults, injuries, diseases andsyndromes. Moreover, various embodiments described herein as aproprietary method and system provide an improvement in the field ofimplantable medical devices and neurocatheters in particular. Still yet,various embodiments described herein as a proprietary method and systemprovide an improvement in the field of neurocatheters that can be usedto carry out positive pressure infusions of therapeutic agents into thebrain, particularly for the purpose of avoiding the screening effects ofthe blood-brain barrier. Additionally, various embodiments describedherein as a proprietary method and system provide an improvement in thefield of neurocatheters that are multi-lumen devices. Further, variousembodiments described herein as a proprietary method and system providean improvement regarding treatment that requires successive delivery ofinitial and follow-up doses of therapeutic agents, or successivedelivery of a first and then subsequent different therapeutic agents,into the same location or set of locations within a brain of a patient.Various embodiments described herein as a proprietary method and systemadditionally improve the ability to the use of multi-lumen catheters inbody parts, ducts, tissues and organs other than the brain, includingthe vasculature.

Various embodiments of the technology, described herein as a proprietarymethod, structure, apparatus and/or system, provide a capability ormeans for delivering therapies into the bulk brain tissues or other bodyparts or ducts, including the vasculature, using a novel arrangement ofcoaxial catheters that constitute a single implantable medical device. Astructure, system or means for accomplishing this may include a catheterwith a fixed number of port holes that is inserted into a brain (orother region of the anatomy) of a patient or subject using any format ofimaging and guidance deemed appropriate by the neurosurgeon orinterventionalist caring for the patient. Such insertion format,procedure or means might include, but not be limited to, any kind ofstereotactic system and procedure, or any kind ofmagnetic-resonance-based trajectory guidance. The catheter mayconstitute the outer tube of a multi-tube coaxial system. Then, a secondcatheter with a particular arrangement of port holes is inserted intothe inside of the barrel of the outer catheter. The second catheter isthen referred to as the inner catheter of this multi-tube coaxialsystem. In an embodiment, the inner catheter may have componentsconstituting a sealing system, such as a kind of sealing gasket locatedaround its circumference above and below the port holes in it. Inanother embodiment, the outer catheter may have components constitutinga kind of sealing system such as a sealing gasket located around itsinner circumference above and below the port holes in it. The port holeson the inner catheter may be arranged to allow communication with theinternal chambers of the inner catheter. An illustrative example ofmedium communication and control may be provided by referring to U.S.Pat. No. 6,464,662 B1 to Raghavan et al., U.S. patent application Ser.No. 10/444,884 to Kucharczyk et al., filed May 23, 2003, U.S. Pat. No.6,599,274 to Kucharczyk et al., and U.S. patent application Ser. No.11/105,166 to Kucharczyk et al., filed Apr. 13, 2005, of which all ofthe disclosures are hereby incorporated by reference herein in theirentirety. Fluids can be pumped through the internal chambers of theinner catheter and exit through the port holes in its wall. When theinner catheter is inserted and aligned within the outer catheter suchthat the port holes on the two tubes are congruent with each other, thefluid (for example, a diagnostic or therapeutic agent) or applicablemedium can then be delivered through the sequence of port holes into abrain of a patient. The gasket or sealing means in either class ofdesign will seal the inter-tube passage way (gap) such that none of thetherapeutic agent can reflux through the inter-tube passage way (gap).Any air trapped within the outer catheter during the insertion of theinner catheter can escape through a channel on the inside of the innercatheter via a distal-end opening on the inner catheter thatcommunicates with the internal channel of the inner catheter for thatpurpose. Friction-fit, elastic conformance, threaded, bayoneted, tabbedor other types of locking mechanisms in the hub of the outer catheterwill allow fixation of the inner catheter relative to the outer catheterat desired axial and circumferential positions that will ensure properalignment of the port holes on both tubes. One or more internal chambersof the inner catheter may serve as flush lines for voiding the innercatheter of one type of infused agent before beginning the process ofdelivering a second type of infused agent. Likewise, the flushingmechanism and/or inner catheter can also be employed for protocols inwhich fluids or applicable medium are being withdrawn from a brain of apatient or from a different body part or duct, including thevasculature. Volume contoured delivery of diagnostic and therapeuticagents, i.e., the creation of volumes of distribution that are adjustedto the geometry of the lesion or target location being treated, will bepossible using this device, simply by relocating the inner catheterrelative to the outer catheter, for example during the course of aninfusion protocol. Delivery of a sequence of agents into desiredlocations within a brain or some other body part or duct, including thevasculature, of a patient will be possible without reinsertion of theouter catheter through the brain or other tissues or vasculature bysimply flushing the inner catheter and then reusing it, or by withdrawalof a given inner catheter and insertion of another inner catheter intothe fixed-position outer catheter. Magnetic resonance spectroscopy ofthe region of the brain surrounding the tip of the catheter could becarried out via the placement of appropriate microcoils at locations onthe distal end (as well as other desired locations) of the outercatheter.

An aspect of an embodiment of the present invention system provides acatheter or similar device for transferring at least one medium with asubject. The catheter or similar device having a distal end and aproximal end. The device comprising: an outer tube having a distal endand a proximal end, and having a wall extending longitudinally therebetween; an inner tube disposed within the outer tube, the inner tubehaving a distal end and a proximal end, and having a wall extendinglongitudinally there between defining a inner tube flow area fortransference of the medium; a longitudinal space between the outer tubeand inner tube defining an inter-tube gap; at least one outer tubeaperture disposed on the outer tube wall; at least one inner tubeaperture disposed on the inner tube wall; the inner tube being adaptedto move longitudinally and/or circumferentially relative to the outertube to provide for the at least one inner tube aperture to be incommunication with the at least one outer tube aperture to allowtransference of the medium between the inner tube and the subject; and asealing system disposed in the inter-tube gap to control the medium fromtraveling within the inter-tube gap.

An aspect of an embodiment of the present invention provides a methodfor delivering at least one medium to a subject using a catheter orsimilar device. The method comprises: inserting an outer tube into thesubject, the outer tube having a distal end and a proximal end andcomprising at least one aperture there between; disposing an inner tubewithin the outer tube, the inner tube having a distal end and a proximalend and comprising at least one aperture there between; providing the atleast one medium into the inner tube; and aligning the outer tubeaperture and the inner tube aperture to allow the at least one medium totravel through the inner tube aperture and outer tube aperture to thesubject while controlling the medium from traveling between the exteriorof the inner tube and interior of the outer tube. Additionally, themethod may further comprise withdrawing a medium from the subject byaligning the outer tube aperture and the inner tube aperture to allowthe at least one medium to travel from the subject through the outertube aperture and inner tube aperture to the inner tube whilecontrolling the medium from traveling between the exterior of the innertube and interior of the outer tube.

An aspect of an embodiment of the present invention provides a methodfor withdrawing at least one medium to a subject using a catheter orsimilar device. The method comprising: inserting an outer tube into thesubject, the outer tube having a distal end and a proximal end andcomprising at least one aperture there between; disposing an inner tubewithin the outer tube, the inner tube having a distal end and a proximalend and comprising at least one aperture there between; and aligning theouter tube aperture and the inner tube aperture to allow the at leastone medium to travel from the subject through the outer tube apertureand inner tube aperture to the inner tube while controlling the mediumfrom traveling between the exterior of the inner tube and interior ofthe outer tube.

These and other aspects of the disclosed technology and systems, alongwith their advantages and features, will be made more apparent from thedescription, drawings and claims that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated into and form a partof the instant specification, illustrate several aspects and embodimentsof the present invention and, together with the description herein,serve to explain the principles of the invention. The drawings areprovided only for the purpose of illustrating select embodiments of theinvention and are not to be construed as limiting the invention.

FIG. 1 is a schematic diagram showing a patient, or any subject orobject, undergoing an examination and/or intervention in an MRI magnetwhereby a catheter device is disposed within the patient.

FIG. 2 is a schematic elevational view of a portion of a catheter havingan outer catheter or outer tube which has an empty inner barrel intowhich inner catheter or inner tube (not shown) can be inserted, removed,translated and/or rotated therein.

FIGS. 3(A)-(B) are schematic elevational views of a portion of acatheter having an outer catheter or tube disposed within an innercatheter tube wherein their respect apertures are misaligned andaligned, respectively.

FIG. 4 schematically represents an embodiment of a coupling mechanismfor the inner catheter or tube and outer catheter or tube device.

FIG. 5(A)-(B) are schematic illustrations of a portion of the proximalend of the catheter device demonstrating exemplary embodiments of mediumentry points or approaches for the inner catheter.

FIG. 6(A) provides a schematic elevational view from the distal end anembodiment of an inner catheter in which the interior of the innercatheter has been divided along its axial length into a plurality ofchambers or the like.

FIG. 6(B) is a schematic elevational view of the distal end of anembodiment the inner catheter, in which the distal tip/end of the innercatheter has a closure surface sealing the three chambers, except thatan aperture is provided through the closure surface in one or more thechambers to serve as the air escape port (or other function) for the airtrapped within the outer catheter.

FIG. 6(C) is schematic elevational view of the distal end of an innercatheter means in which the aperture is an orifice formed at the distalend formed from the entire chamber to provide an air escape port (orother function).

FIG. 7 shows a perspective schematic view of the distal tip of an innercatheter means in which a segment of the air escape channel is shownleading towards the proximal end (not shown) of the inner catheterdevice and away from the orifice of the distal end.

FIG. 8 is a perspective schematic view an alternative embodiment of acoupled inner and outer catheter combination, in which inner catheterhas a longitudinal pattern of port holes, and further includes innerchambers that are in communication with the apertures on the closedsurface of the distal end of the inner catheter.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram showing a patient 110, or any subject orobject, undergoing an examination and/or intervention inside the bore ofan MRI system 112 whereby a catheter device is disposed within thepatient. A manifold 114 couples several therapeutic or diagnosticdevices typified by device 116 to the cell delivery catheter 118. Asyringe, flow-driver or pumping device 124 is also in communication withthe manifold 114. The cell delivery catheter 118 in turn may bedelivered through a guide sheath 120 that may be positioned in anavigation guide 122. In operation the physician or user inserts thecatheter device 118 into the brain (or other anatomy part or subjectregion) under MRI guidance or other applicable examination orintervention. The same or similar MRI visualization may be used tofollow the progress of the implant both acutely and chronically. Thisspecific version of the catheter within the generic concepts disclosedherein may have an outer catheter/tube with an inner catheter/tubewithin that will be described in greater detail herein. This catheterdevice may have various interior and peripheral lumens, chambers andchannels that will also be discussed in greater detail herein, withinthe context of the generic disclosure provided. Such interior andperipheral lumens, chambers and channels may be used to deliver otherdevices and perform various diagnostic functions. For example, eachlumen, chamber, and channel may communicate with a separate port of themanifold 114. A lumen, chamber or channel may contain a pressuretransducer 128. Other lumens and channels may be devoted to an opticalcell counter device, for example, as shown generically as device 119 inFIG. 1. Such a device may operate with two fibers located in twoseparate lumens and/or ports to measure the number of and viability ofcells delivered by the catheter. An example of fiber optics relatedapplication/technology is discussed in U.S. patent application Ser. No.10/444,884, filed May 23, 2003 (U.S. 2003/0204171, published Oct. 30,2003).

It should be appreciated, that as discussed herein a subject may be ahuman or any animal. It should be appreciated that an animal may be avariety of any applicable type, including, but not limited thereto,mammal, veterinarian animal, livestock animal or pet type animal, etc.As an example, the animal may be a laboratory animal specificallyselected to have certain characteristics similar to human (e.g. rat,dog), etc. It should be appreciated that the subject may be anyapplicable patient, for example.

FIG. 2 is a schematic elevational view of a portion of a catheter 2having an outer catheter 10 or outer tube which has an empty innerbarrel into which inner catheter 30 or inner tube (not shown) can beinserted, removed, translated and rotated during the course, forinstance, of neurosurgical or neurointerventional procedures. The outercatheter 10 or outer tube has an arrangement of apertures 12 such as aport hole means placed in its wall 14 in an appropriate or desiredpattern. In one specific embodiment as shown here, the port holes 12 arein a circumferential arrangement, with at least three sets of themlocated along the longitudinal axis, LA-O, of the outer catheter 10. Theapertures 12 may be arranged and located circumferentially andlongitudinally as required.

Referring to FIGS. 3(A)-3(B), the inner catheter 30 or inner tube may beinserted, removed, translated, or rotated within the outer catheter 10,and typically will be substantially coaxially aligned with the outercatheter 10 although that is not a requirement. The space between theouter wall of the inner catheter 10 and the inner wall of the outercatheter 30 is defined as an inter-tube gap 18. The inner catheter 30has at least one or more apertures, such as port hole means 32, locatedcircumferentially at or proximal to its distal tip/end/region 34. Thedistal tip/end 34 of inner catheter 30 has a sealing device or system 36(or other structure to block the transference of a given medium) such asa plurality of circumferential gaskets located on either side of theaperture or port hole means 32. In one specific embodiment, the sealingdevice or system 36 might be similar to gaskets, o-ring seals or anothertype of annular means that projects above the surface of the innercatheter 30, coplanar with the surface of the catheter, below thesurface of the outer catheter 10 or otherwise positioned within theinter-tube gap 18. Other examples of the sealing device or function maybe provided by, but not limited thereto, the following: sleeve, grommet,bushing, annular rivet, snap closure, slip, pressure seal, elastic seal,pneumatic tension seal, collar, engaged seal, engaged joint, tab,offset, protuberance, shelf, ledge, extension, lip, bulge, collet,flange, thimble, or ring, knob, friction-fit communication between theinner tube and outer tube, elastic conformance, threaded-fit,bayoneted-fit, or other types of locking mechanisms or circumferentialsealing devices or systems. Among the functions that may be provided bythis sealing system is the reduced ability of materials to flow into andout of a hole in the outer catheter (tube), where such flow is notintended. For example, if there were a gap between the inner catheter(tube) and the outer catheter (tube), and holes in the inner catheterand outer catheter were aligned to allow diffusion of materials releasedfrom the inner catheter through the hole in the outer catheter,materials in the environment to which perfusion is to be effected couldreflux into a space between the inner and outer catheters and materialstrapped or located in that space between the inner and outer catheterscould migrate or otherwise transfer into that environment or be releasedat another unintended time and location. One function of the seal systemor device is to reduce any such unintended capture and/or release ofmaterials, including materials present in space between the inner andouter catheter. The seal may also operate to reduce mass transfer ofmaterials back into the openings in the inner and outer catheters,preventing other spurious concentration changes in materials to bedelivered and/or reduce dilution of materials to be delivered and/orprevent spurious transport of materials from one environment to anotherenvironment by being picked up through transfer into space carried in oraround the inner and/or outer catheter. As will be discussed later, forvarious embodiments the inner catheter 30 will generally have multipleinner chambers, channels or lumens each constituting a separate lumen ofthe device that communicates with an inlet on the proximalend/tip/region 35 (not shown) of the inner catheter 30. One example ofsuch an inner chamber is shown as an intra-inner tube lumen 38.Referring to FIG. 3(A), the inner catheter 30 and outer catheter areshown positioned or located such that the inner catheter aperture(s) 32and outer catheter aperture(s) 12 are not aligned in manner so as toprevent any transference of medium there through. For example, themedium could not be transferred or exchanged between the subject and theinner catheter/tube 30 via the pathway of the inner catheter apertures32 and outer catheter apertures 12 combination. Alternatively, Referringto FIG. 3(B), the inner catheter 30 and outer catheter are shownpositioned or located such that the inner catheter aperture(s) 32 andouter catheter aperture(s) 12 are at least partially aligned orcongruent with one another such that a medium can be transferred betweenthe inner tube 30 and the subject 4 via the pathway of the innercatheter aperture(s) 32 and outer catheter aperture(s) 12 combination.Some examples of medium that may be transferred from the inner tube tothe subject may include, but not limited thereto, the following:therapeutic and diagnostic agents, for example, chemotherapies, cellslurries, gene therapy vectors, growth factors, contrast agents,angiogenesis factors, radionuclide slurries, anti-infection agents,anti-tumor compounds, receptor-bound agents and/or other types of drugs,therapeutic and/or diagnostic agents, and other such substances.

Similarly, some examples of medium that may be transferred (i.e.,withdrawn) from the subject to the inner tube may include, but notlimited thereto, the following: edematous fluids, blood, cerebrospinalfluid, interstitial fluid, infected materials, neoplastic fluids andtissues, and other such substances.

It should be appreciated that the inner catheter tube 30 and outercatheter 10 tube may be comprised of a variety structures including, butnot limited thereto, the following: constituting various types ofconduits, channels, passages, pipes, tunnels, and/or bounded tubularsurfaces or the like. Moreover, the tubes may have a variety ofcross-sectional shapes including, but not limited to the followinggeometric shapes: circular, oval, multi-faceted, square, rectangular,hexagonal, octagons, parallelogram hexagonal, triangular, ellipsoidal,pentagonal, octagonal, or combinations thereof or other desired shapes,including variable diameter or cross-section geometries and irregulargeometries.

Further, it should be appreciated that any of the apertures discussedherein may have a variety of shapes such as, but not limited thereto,the following circular, oval, multi-faceted, square, rectangular,hexagonal, octagons, parallelogram hexagonal, triangular, ellipsoidal,pentagonal, octagonal, or combinations thereof or other desired shapes.

Similarly, the apertures discussed herein may be of a variety structuressuch as, but not limited thereto, the following: recess, port, duct,trough, bore, inlet, hole, perforation, channel, passage, slot, orificeor the like.

Moreover, it should be appreciated that the various components of theinner and outer catheter may be a variety of commercially availablematerials used for all types of catheter systems. Some examples ofmaterials used for the inner and outer catheters may include, but notlimited thereto, the following: polymers, rubber, plastic, composites,metals, ceramics, hydrogels, dialysis membranes and other membranousmaterials, MR-compatible alloys and materials, and other organic andinorganic compounds and substances and the like. It should beappreciated that the various components of the catheter system 2,including but not limited thereto, the outer tube 10, sealing device 46and inner tube 30 may be flexible or rigid and combination thereof asrequired or desired for intended use. Similarly, the catheter system 2,including but not limited thereto, the outer tube 10, sealing device 46and inner tube 30 may provide volume contoured delivery/withdrawal(i.e., transfer) of a medium by adjusting its geometry andflexibility/rigidity according to the target location or anatomy (orregion, including structure and morphology of any lesion) being treated.

FIG. 4 schematically represents one specific embodiment of a couplingmechanism 60 that is within the generic scope of coupling mechanismscontemplated herein for the inner catheter 30 or inner tube and outercatheter 10 or outer tube means/device. In a simple exemplary form ofthis system, one version of the inner catheter 30 as shown, is fittedwith a sequence of markings 40, each located at desired points, forexample about 1 cm from the other, along the longitudinal axis, LA-I, ofinner catheter 30. It should be appreciated that the distance betweenany of the points on the outer catheter or inner catheter may vary asdesired or required. A port 50, such as a Luer port or the like (as wellas other desired or required ports, manifolds, instruments orcomponents) is located at the proximal end 35 of inner catheter 30, inorder to fit a syringe or other fluid delivery or extraction device tothe inner catheter 30. The inner catheter 30 may be slid or advancedinto the outer catheter 10 through a coupling 60 or locking device, suchas a screw-locking hub or the like having threaded cap 62 which can betightened by hand onto a coupling hub base 64.

FIGS. 5(A)-(B) are schematic illustrations of a portion of the proximalend 35 of the catheter device 2 demonstrating exemplary embodiments ofmedium entry points or approaches for the inner catheter 30. Referringto FIG. 5(A), FIG. 5(A) is a schematic illustration of a partial portionof the inner catheter 30, wherein the upper lip of the port 50, e.g.,Luer fitting, may have an extra seal 54 that is designed to provide anextra degree of certainty that there shall be no leakage when a deliverymeans (or retrieval means) such as a syringe is mated into the Luerport/means 50.

Referring to FIG. 5(B), FIG. 5(B) is a schematic illustration of analternative embodiment wherein the Luer port/means 50 is provided so asto form an inner catheter hub 55. The inner catheter has a Luerport/means 50 that accommodates a second Luer port/fitting 52 that mightbe used to drive water, air or any other kind of liquid or gaseous fluidthrough internal flush line 70. In this particular embodiment, a fitting56 has been added to the base of Luer port/fitting 50 to provide a meansfor holding the inner catheter upper hub assembly 55 tightly whilefitting syringes or other fluid driver or extractor means into the Luerports 50 and 52.

FIG. 6(A) provides a schematic elevational view from the distal end anembodiment of an inner catheter 30 in which the interior of the innercatheter 30 has been divided along its entire axial length (or at leasta portion of its length as necessary to accomplish it's intendedfunction) into three chambers 42 separated by a divider, wall orpartition means 46. For example, one of the chambers 42 can server asthe air-escape means, a second chamber 42 can serve as an agent deliverymeans, and a third chamber 42 can serve as a flushing channel means. Itshould be appreciated that the one or more chambers may be utilized asrequired or desired. Furthermore, other functions of these chambers(lumens or channels) may also include user-controlled constriction ofthe chamber, lumen or channel volume for the purpose of regulating orblocking a flow through the chamber, lumen or volume; simultaneousdelivery of different agents or materials through a plurality ofchambers, lumens or volumes to achieve mixing of the agents or materialsupon delivery; transport of an agent or material between one chamber,lumen or volume and another one via an internal membranous structure ina dialysis-like or osmotic fashion; and the like.

FIG. 6(B) is a schematic elevational view of the distal end of anembodiment the inner catheter 30, in which the distal tip/end 34 of theinner catheter 30 has closure surface 46 sealing the three chambers 42,except that an aperture 48 is provided through the closure surface 46 inone of the chambers to serve as the air escape port for the air trappedwithin the outer catheter 10 by virtue, for example, the inner catheter30 being inserted into (rotated or retracted from) the outer catheter10.

FIG. 6(C) is schematic elevational view of the distal end 34 of an innercatheter means 30 in which rather than having aperture 48, as previouslyshown in see FIG. 6(B), that serves as the air escape means, instead anentire chamber of the distal end of 34 may be uncovered from closuresurface 46, resulting in an orifice 49, in order to maximize the ease ofescape of air trapped inside the outer catheter 10. For instance, airmay be trapped inside the outer catheter as a result of the innercatheter 30 being inserted (rotated or retracted from) into the outercatheter 10.

FIG. 7 shows a perspective schematic view of the distal tip 34 of aninner catheter means 30 in which a segment of the air escape channel 74is shown leading towards the proximal end 35 (not shown) of the innercatheter device 30 and away from the orifice 49 of the distal end 34.Also shown is the orifice structure 49 and port hole structure/means 32in relation to sealing device 36, such as a gasket means or the like.

FIG. 8 is a perspective schematic view an alternative embodiment of acoupled inner and outer catheter combination, in which inner catheter 30has a longitudinal pattern of port holes 32, and further includes innerchambers 76 and 78 that are in communication with the apertures 48 onthe closed surface 46 at the distal end of the inner catheter 30. Asdiscussed earlier, the port holes 32 of the inner catheter 30 can bealigned circumferentially and/or longitudinally with port hole means 12of the outer catheter means 10 such that an overlap allows an out-flowof a therapeutic agent, for example, toward the subject. A microcoildevice 16, as generically shown, may be located at the tip of outercatheter means 10 to help enable high contrast magnetic resonanceimaging or magnetic resonance spectroscopy measurement of speciesproximal to the tip of outer catheter 10 in a brain or other locationsof a patient or subject. A plurality of the microcoil devices may beused on any combination of the catheter system 2 to best accomplish themagnetic resonance imaging or spectroscopy.

An example of a coil device 16, may be a radio frequency (RF) microcoilthat may be wound circumferentially on the outer tube. An RF microcoilsystem may be wound circumferentially on both the outer tube and/or theinner tube. The physical and electrical characteristics of the RFmicrocoil elements are such as to enhance the contrast of magneticresonance images made of body parts into which the catheter meansincorporating the microcoil elements are inserted. Active MRvisualization of drug, cell, and gene vector delivery can be achieved bymeans of one or more RF microcoils positioned on the catheter asdisclosed in U.S. Pat. No. 6,026,316 to Kucharczyk et al. Singlemicrocoils may be used separately or the combination of microcoils maybe constructed in an array that may be used together to optimally imagethe surrounding environment, including the tissue structure and functionwithin the field of response of the microcoils. The system of microcoilsmay, by way of non-limiting example, be used for very small (picoliter,nanoliter or microliter) injections measured within a solenoid volume RFmicrocoil, which by design is mainly sensitive to the volume inside thecoil. The imaging volume in such a use is usually directly related tothe diameter of the RF coil.

One skilled in the art can appreciate that many other embodiments ofinner and outer catheter means, port hole means, inner chamber means,inner or outer tube gasket or sealing means, interconnection and hubmeans, micro coil means, and other details of construction constitutenon-inventive variations of the novel and insightful conceptual means,system and technique which underlie the present invention.

Still other embodiments will become readily apparent to those skilled inthis art from reading the above-recited detailed description anddrawings of certain exemplary embodiments. It should be understood thatnumerous variations, modifications, and additional embodiments arepossible, and accordingly, all such variations, modifications, andembodiments are to be regarded as being within the spirit and scope ofthis application. For example, regardless of the content of any portion(e.g., title, field, background, summary, abstract, drawing figure,etc.) of this application, unless clearly specified to the contrary,there is no requirement for the inclusion in any claim herein or of anyapplication claiming priority hereto of any particular described orillustrated activity or element, any particular sequence of suchactivities, or any particular interrelationship of such elements.Moreover, any activity can be repeated, any activity can be performed bymultiple entities, and/or any element can be duplicated. Further, anyactivity or element can be excluded, the sequence of activities canvary, and/or the interrelationship of elements can vary. Unless clearlyspecified to the contrary, there is no requirement for any particulardescribed or illustrated activity or element, any particular sequence orsuch activities, any particular size, speed, material, dimension orfrequency, or any particularly interrelationship of such elements.Accordingly, the descriptions and drawings are to be regarded asillustrative in nature, and not as restrictive. Moreover, when anynumber or range is described herein, unless clearly stated otherwise,that number or range is approximate. When any range is described herein,unless clearly stated otherwise, that range includes all values thereinand all sub ranges therein. Any information in any material (e.g., aUnited States/foreign patent, United States/foreign patent application,book, article, etc.) that has been incorporated by reference herein, isonly incorporated by reference to the extent that no conflict existsbetween such information and the other statements and drawings set forthherein. In the event of such conflict, including a conflict that wouldrender invalid any claim herein or seeking priority hereto, then anysuch conflicting information in such incorporated by reference materialis specifically not incorporated by reference herein.

1. A catheter device for transferring at least one medium with asubject, wherein said catheter having a distal end and a proximal end,said device comprising: an outer tube having a distal end and a proximalend, and having a wall extending longitudinally there between; an innertube disposed within said outer tube, said inner tube having a distalend and a proximal end, and having a wall extending longitudinally therebetween defining a inner tube flow area for transference of the medium;a longitudinal space between said outer tube and inner tube defining aninter-tube gap; at least one outer tube aperture disposed on said outertube wall; at least one inner tube aperture disposed on said inner tubewall; said inner tube being adapted to move longitudinally and/orcircumferentially relative to said outer tube to provide for said atleast one inner tube aperture to be in communication with said at leastone outer tube aperture to allow transference of the medium between saidinner tube and the subject; and a sealing system disposed in saidinter-tube gap to control the medium from traveling within saidinter-tube gap.
 2. The device of claim 1, wherein said seal systemcontrols medium travel in said inter-tube gap in the direction of thecatheter proximal end and the distal end.
 3. The device of claim 1,wherein control of the medium travel by said seal system is reduction oftravel.
 4. The device of claim 3, further comprising a passage disposedon said catheter device extending from said catheter distal end towardcatheter proximal end adapted to allow air to pass there through as aresult of the relative movement of said inner tube and said outer tube.5. The device of claim 3, wherein said seal system is selected from thegroup of structures consisting of flange, collet, gasket, engaged seal,joint, sleeve, grommet, bushing, annular rivet, snap closure, slip,pressure seal, elastic tension seal, pneumatic tension seal, tab,offset, protuberance, shelf, ledge, extension, lip, bulge, collet,flange, collar thimble, or ring, knob, friction-fit communicationbetween the inner tube and outer tube, elastic conformance,threaded-fit, bayoneted-fit, locking mechanisms and circumferentialsealing devices.
 6. The device of claim 1, wherein control of the mediumtravel by said seal system is prevention of travel.
 7. The device ofclaim 6, further comprising a passage disposed on said catheter deviceextending from said catheter distal end toward catheter proximal endadapted to allow air to pass there through as a result of the relativemovement of said inner tube and said outer tube.
 8. The device of claim6, wherein said seal system is selected from the group of structuresconsisting of flange, collet, gasket, engaged seal, joint, sleeve,grommet, bushing, annular rivet, snap closure, slip, pressure seal,elastic tension seal, pneumatic tension seal, tab, offset, protuberance,shelf, ledge, extension, lip, bulge, collet, flange, collar, thimble, orring, knob, friction-fit communication between the inner tube and outertube, elastic conformance, threaded-fit, bayoneted-fit, lockingmechanisms and circumferential sealing devices.
 9. The device of claim1, further comprising a passage disposed on said catheter deviceextending from said catheter distal end toward catheter proximal endadapted to allow air to pass there through as a result of the relativemovement of said inner tube and said outer tube.
 10. The device of claim9, wherein said passage comprises a lumen.
 11. The device of claim 9,wherein said passage comprises at least one of the following: conduit,channel, passage, pipe, tunnel, tube or bounded tubular surface.
 12. Thedevice of claim 9, wherein said passage being adapted to allow flushingof a residual medium existing in said inner tube.
 13. The device ofclaim 1, wherein said transference of the medium comprises deliveringthe medium from said inner tube to the subject.
 14. The device of claim13, wherein said delivered medium comprises at least one ofchemotherapies, cell slurries, gene therapy vectors, growth factors,contrast agents, angiogenesis factors, radionuclide slurries,anti-infection agents, anti-tumor compounds, receptor-bound agentsand/or other types of drugs, therapeutic and/or diagnostic or agents.15. The device of claim 1, wherein said transference of the mediumcomprises withdrawing the medium from the subject to said inner tube.16. The device of claim 15, wherein said withdrawn medium comprises atleast one of edematous fluids, blood, cerebrospinal fluid, interstitialfluid, infected materials, neoplastic fluids and tissues and other suchsubstances.
 17. The device of claim 1, wherein said inner tube comprisesa catheter.
 18. The device of claim 1, wherein said inner tube comprisesat least one of the following: conduit, channel, passage, pipe, tunnel,or bounded tubular surface.
 19. The device of claim 1, wherein saidouter tube comprises a catheter.
 20. The device of claim 1, wherein saidouter tube comprises at least one of the following: conduit, channel,passage, pipe, tunnel, or bounded tubular surface.
 21. The device ofclaim 1, further comprising: a flushing passage disposed on saidcatheter device extending from said catheter distal end toward saidcatheter proximal end adapted to allow flushing of a residual mediumexisting in said inner tube.
 22. The device of claim 21, wherein saidflushing passage is disposed inside said inner tube.
 23. The device ofclaim 21, wherein said flushing passage is disposed on said inner tube.24. The device of claim 1, further comprising: a second passage disposedon said catheter device extending from said catheter distal end towardsaid catheter proximal end adapted to allow a transference of a secondmedium with the subject.
 25. The device of claim 24, wherein said innertube being adapted to move longitudinally and/or circumferentiallyrelative to said outer tube to provide for said second passage to be incommunication with said at least one outer tube aperture to allowtransference of the second medium between said inner tube and thesubject.
 26. The device of claim 24, wherein the second medium comprisesat least one of the following: therapeutic agent, diagnostic agent,chemotherapies, cell slurries, gene therapy vectors, growth factors,contrast agents, angiogenesis agents, and other such substances.
 27. Thedevice of claim 24, wherein said second passage is disposed inside saidinner tube.
 28. The device of claim 24, wherein said second passage isdisposed on said inner tube.
 29. The device of claim 24, furthercomprising: a third passage disposed on said catheter device extendingfrom said catheter distal end toward catheter proximal end adapted toallow a transference of a third medium with the subject.
 30. The deviceof claim 29, wherein said inner tube being adapted to movelongitudinally and/or circumferentially relative to said outer tube toprovide for said third passage to be in communication with said at leastone outer tube aperture to allow transference of the third mediumbetween said inner tube and the subject.
 31. The device of claim 1,wherein the medium comprises at least one of the following: diagnosticagent, therapeutic agent, chemotherapies, cell slurries, gene therapyvectors, growth factors, contrast agents, angiogenesis agents, and othersuch substances.
 32. The device of claim 1, wherein said sealing systemcomprises at least one of gasket, o-ring, sleeve, grommet, bushing,annular rivet or other type of circumferential sealing device.
 33. Thedevice of claim 1, wherein said sealing system comprises at least one oftab, offset, protuberance, shelf, ledge, extension, lip, bulge, collet,flange, thimble, ring or knob.
 34. The device of claim 1, wherein saidseal system is selected from the group of structures consisting of snapclosure, slip, pressure seal, elastic tension seal, collar, elasticconformance, threaded-fit, bayoneted-fit, locking mechanisms, engagedseal, and joint.
 35. The device of claim 1, wherein said sealing systemcomprises friction-fit communication between said inner tube and outertube.
 36. The device of claim 1, wherein said sealing system preventsreflux of the medium.
 37. The device of claim 1, wherein during saidprevention of the medium traveling in said inter-gap, said sealingsystem is located longitudinally on the distal end side and proximal endside of said outer tube aperture and located longitudinally on thedistal end side and proximal end side of said inner tube aperture. 38.The device of claim 1, wherein areas of the subject for use with saiddevice comprises at least one of: tissues, ducts, organs, andvasculature.
 39. The device of claim 1, wherein areas of the subject foruse with said device comprises brain tissues.
 40. The device of claim 1,further comprising at least one microcoil in communication with saidcatheter device.
 41. The device of claim 40, wherein said at least onemicrocoil is disposed on said catheter device.
 42. A method fordelivering at least one medium to a subject using a catheter device,wherein said method comprises: inserting an outer tube into the subject,said outer tube having a distal end and a proximal end and comprising atleast one aperture there between; disposing an inner tube within saidouter tube, said inner tube having a distal end and a proximal end andcomprising at least one aperture there between; providing the at leastone medium into said inner tube; and aligning said outer tube apertureand said inner tube aperture to allow the at least one medium to travelthrough said inner tube aperture and outer tube aperture to the subjectwhile controlling the medium from traveling between the exterior of saidinner tube and interior of said outer tube.
 43. The method of claim 42,wherein said controlling is a prevention of travel.
 44. The method ofclaim 43, further comprising allowing trapped air inside said outer tubein vicinity of the distal end of said outer tube to escape when saidinner tube is disposed into said outer tube.
 45. The method of claim 42,wherein said controlling comprises preventing the medium from travelingin the direction of the catheter proximal end and the distal end. 46.The method of claim 42, wherein said controlling is a reduction oftravel.
 47. The method of claim 46, further comprising allowing trappedair inside said outer tube in vicinity of the distal end of said outertube to escape when said inner tube is disposed into said outer tube.48. The method of claim 42, wherein said controlling comprises reducingthe medium from traveling in the direction of the catheter proximal endand the distal end.
 49. The method of claim 42, further comprisingallowing trapped air inside said outer tube in vicinity of the distalend of said outer tube to escape when said inner tube is disposed intosaid outer tube.
 50. The method of claim 42, wherein the medium beingdelivered comprises at least one of chemotherapies, cell slurries, genetherapy vectors, growth factors, contrast agents, angiogenesis factors,radionuclide slurries, anti-infection agents, anti-tumor compounds,receptor-bound agents and/or other types of drugs, therapeutic and/ordiagnostic or agents.
 51. The method of claim 42, further comprisingwithdrawing a medium from the subject, said method comprising: aligningsaid outer tube aperture and said inner tube aperture to allow the atleast one medium to travel from the subject through said outer tubeaperture and inner tube aperture to the inner tube while controlling themedium from traveling between the exterior of said inner tube andinterior of said outer tube.
 52. The method of claim 51, wherein saidcontrolling is a prevention of travel.
 53. The method of claim 52,further comprising allowing trapped air inside said outer tube invicinity of the distal end of said outer tube to escape when said innertube is disposed into said outer tube.
 54. The method of claim 51,wherein said controlling comprises preventing the medium from travelingin the direction of the catheter proximal end and the distal end. 55.The method of claim 51, wherein said controlling is a reduction oftravel.
 56. The method of claim 55, further comprising allowing trappedair inside said outer tube in vicinity of the distal end of said outertube to escape when said inner tube is disposed into said outer tube.57. The method of claim 51, wherein said controlling comprises reducingthe medium from traveling in the direction of the catheter proximal endand the distal end.
 58. The method of claim 51, further comprisingallowing trapped air inside said outer tube in vicinity of the distalend of said outer tube to escape when said inner tube is disposed intosaid outer tube.
 59. The method of claim 51, wherein the medium beingwithdrawn comprises at least one of edematous fluids, blood,cerebrospinal fluid, interstitial fluid, infected materials, neoplasticfluids and tissues, and other such substances.
 60. The method of claim42, wherein said catheter is positioned under non-invasive imagingguidance.
 61. The method of claim 42, wherein said catheter ispositioned near a targeted area of treatment using non-invasive imagingguidance.
 62. A method for withdrawing at least one medium to a subjectusing a catheter device, wherein said method comprising: inserting anouter tube into the subject, said outer tube having a distal end and aproximal end and comprising at least one aperture there between;disposing an inner tube within said outer tube, said inner tube having adistal end and a proximal end and comprising at least one aperture therebetween; and aligning said outer tube aperture and said inner tubeaperture to allow the at least one medium to travel from the subjectthrough said outer tube aperture and inner tube aperture to the innertube while controlling the medium from traveling between the exterior ofsaid inner tube and interior of said outer tube.
 63. The method of claim62, wherein said controlling is a prevention of travel.
 64. The methodof claim 63, further comprising allowing trapped air inside said outertube in vicinity of the distal end of said outer tube to escape whensaid inner tube is disposed into said outer tube.
 65. The method ofclaim 62, wherein said controlling comprises preventing the medium fromtraveling in the direction of the catheter proximal end and the distalend.
 66. The method of claim 62, wherein said controlling is a reductionof travel.
 67. The method of claim 66, further comprising allowingtrapped air inside said outer tube in vicinity of the distal end of saidouter tube to escape when said inner tube is disposed into said outertube.
 68. The method of claim 62, wherein said controlling comprisesreducing the medium from traveling in the direction of the catheterproximal end and the distal end.
 69. The method of claim 62, furthercomprising allowing trapped air inside said outer tube in vicinity ofthe distal end of said outer tube to escape when said inner tube isdisposed into said outer tube.
 70. The method of claim 62, wherein themedium being withdrawn comprises at least one of edematous fluids,blood, cerebrospinal fluid, interstitial fluid, infected materials,neoplastic fluids and tissues, and other such substances.